Enrollment Period Extended through February for Scripps Research Study to Assess Impact of Personal Genetic Testing

Study will assess the behavioral impact of personal genetic testing on adults

San Diego – The public’s opportunity to take part in a landmark personal genetic testing study has been extended, as Scripps Translational Science Institute (STSI) (STSI) has announced a prolonged enrollment period, running from January through February 28, 2009.

This first-of-its-kind research study will assess the behavioral impact that personal genetic testing has on adults 18 and older who choose to receive such screenings to identify their potential risk for developing certain diseases.

The study’s enrollment period initially ran from October through December 2008 and has been extended based on strong public reaction. The general public can find more information about the study at www.navigenics.com/scripps.

Will genetic information encourage positive lifestyle choices?

Sponsored by STSI, the study aims to find out if participating in personal genomic testing will improve health by motivating people to make positive lifestyle changes, such as exercising, eating healthy and quitting smoking, as well as decisions to seek further medical evaluation and preventive strategies.

The study will offer personal genetic scans to up to 10,000 participants and will assess changes in their behaviors over a 20-year period.

Co-sponsors of the study include:

Navigenics Inc. of Redwood Shores, Calif.

Affymetrix of Santa Clara, Calif.

Microsoft Corp. of Redmond, Wash.

Participants receive a genome scan and analysis of health risks

All study participants will receive a scan of their genome and a detailed analysis of their genetic risk for more than 20 health conditions that may be changed by lifestyle, including diabetes, obesity, heart attack and some forms of cancer.

“The initial response to our study was so strong, we decided to give more people an opportunity to learn about it and take part,” said Eric J. Topol, M.D., director of STSI and principal investigator of the study.

“Many people are intrigued to find out what a genome scan tells them about their DNA and risk of disease, and what they can do to help mitigate any risks they may have.”

Affymetrix will scan each participant’s genome and Navigenics will interpret the scan results and offer personalized guidance on steps to lessen the chances of negative health impact. This information will be available to participants on Navigenics’ secure Web site.

Participants can store their information online

Each participant will be able to enter and store clinical and lifestyle information in an individual Microsoft HealthVault account, allowing the participant to manage his or her personal health information in one location and share it, as desired, with health care providers or others they trust to help make more informed health care decisions.

Lifestyle changes will be tracked via participants’ self-reported health assessment questionnaires, including a baseline assessment and subsequent self-reported assessments at three- and 12-month intervals after receiving gene scan results. Researchers will also ask participants to conduct periodic health surveys over the next 20 years to assess their behaviors longitudinally. A complete database of genomic and clinical information will be assembled at the Scripps Genomic Medicine program.

A number of safeguards will be in place to protect the privacy of participants’ genetic information. Traditional identifying information for participants’ saliva samples and self-reported health assessment questionnaires will be de-identified, encoded, encrypted and kept in a secure database.

Study findings used to understand the genetic basis of disease prevention and treatment

Researchers will use the genetic variations found in the study as a tool to continue to study genes linked to many diseases. The study affords researchers the opportunity to better understand ways to prevent, diagnose and treat disease.

About Scripps Translational Science Institute and Scripps Health

Scripps Translational Science Institute (STSI), in conjunction with the National Institute of Health’s Clinical & Translational Science Award (CTSA) consortium, is transforming how clinical and translational research is conducted. Through a variety of activities, STSI endeavors to provide new treatments more efficiently and quickly to patients.

Part of the CTSA consortium, Scripps Health is a $2 billion nonprofit community health system based in San Diego, Calif. with 12,300 employees, five acute-care hospital campuses, home health care services, and an ambulatory care network of clinics and physician offices.